PHOTOCURE ANNOUNCeS SUCCESSFUL PHASE II RESULTs FOR cevira®
Receives FDA approval for studies in US
(Oslo, January 26 2011) Photocure (OSE: PHO), a Norwegian specialty
pharmaceutical company focused in dermatology and cancer, announces final six
month follow up results from its phase IIa study with Cevira® in patients with
low-grade precancerous lesions of the cervix. The results showed a complete
removal of intracervical lesions in over 50% of patients enrolled in the trial.
Photocure also announces that the US FDA has granted permission to start Phase
II clinical studies in the US with Cevira in women with low-grade precancerous
lesions of the cervix using the new intravaginal combination product.
Cervical HPV-induced lesions affect seven million women in Europe and the US
each year. Current treatment of precancerous lesions involves invasive surgical
procedures to remove the precancerous lesions, which can result in the
unnecessary removal of normal cervical tissue. Besides discomfort and recovery
time, this can affect the patient's ability to carry a child full-term, impact
fertility and increase the risk of post-surgical infections. For a large number
of patients with persistent HPV infections and low-grade cellular abnormalities,
there are no currently available non-surgical treatment alternatives, and
frequent follow up visits to avoid further disease progression causes patient
anxiety and adds to the burden for the health care system.
Cevira is being developed as the first non-surgical, therapeutic procedure for
treating cervical HPV infection and precancerous lesions of the cervix. It has
the potential to offer patients and gynaecologists an easy, safe and highly
selective treatment, thus preserving normal surrounding tissue. The procedure
combines hexaminolevulinate (HAL) ointment with a red light LED-source in a
fully integrated disposable delivery system.
In this recently completed Phase IIa study, Cevira 5% vaginal suppositories were
applied for five hours followed by a light dose of 50J/cm(2) (laser) to 70
patients with low-grade cervical lesions (CIN1). At six months, HPV lesions
were completely cleared in 57% of women in the treatment arm as compared to 25%
in the control group (p<0.05). In the active treatment arm of the study, the HPV
response rate correlated with the lesion response in 86% of the women. Cevira
was well tolerated with no serious or severe side effects reported.
To date, more than 200 patients have received Cevira. A recent health economics
survey among US gynaecologists and payers conducted by Photocure confirms the
market need and potential opportunity for Cevira in patients with low and
moderate grade cervical lesions.
"We are encouraged to see that Cevira continues to show high efficacy in
patients with low-grade (CIN1) cervical disease as well as in patients with
moderate-grade lesions (CIN2). Another milestone was reached when our new fully
integrated device and drug recently received FDA approval to initiate studies in
the USA. Photocure is now planning multicenter phase II studies in the US and EU
in patients with cervical HPV infection." said Dr. Kjetil Hestdal, President and
CEO of Photocure.
For further information, please contact:
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
CFO Christian Fekete
Tel: + 47 916 42 938, Email: cf@photocure.no
Capital MS&L
Mary Clark, Justine Lamond and Hollie Vile,
Tel: +44 (0)20 7307 5337, Email: Photocure@capitalmsl.com
Notes to editors
About HPV infection and cervical abnormalities
Persistent HPV infection may cause cervical precancer with a risk of development
to cancer. Screening programs are initiated to find women with cellular
abnormalities who will be followed up or treated to prevent development of
cervical cancer.
Standard treatment of precancer is surgery but with increased risk of side
effects including preterm labour, scarring that may impair fertility, infection
and bleeding, which is undesirable particularly in young women in their
reproductive age. In Europe and US approximately 1 mill women are diagnosed with
cervical precancer annually.
Women with mild cervical abnormalities are followed up frequently with
gynaecological examinations to prevent progression to precancer. The majority of
cervical lesions regress spontaneously, but treatment may be offered in the
persistent conditions. In Europe and US approximately 7 mill women are diagnosed
with mild cervical abnormalities annually.
HPV prophylactic vaccines have recently been introduced to young girls but will
have limited short-term effects on the number of patients developing precancer.
HPV tests are being introduced to the market to address patients at high risk
and will most likely be included in the public screening program.
There is a medical need for a tissue preserving treatment modality in patients
with cervical precancer. Patients with persistent HPV infection and mild
abnormalities have a low risk of progression but all patients need frequent
examinations to rule out progression to precancer. A treatment modality to
eliminate the persistent HPV infection is desirable.
About Cevira
Cevira® is a photodynamic therapy that combines the Cevira ointment with
illumination by a red light source to treat HPV and cervical abnormalities.
Cevira ointment contains HAL (hexaminolevulinate) which is applied together with
the light source to the cervix. After a drug incubation time red light
photoactivation starts and stops automatically, all within 10 hours. The
treatment is administered by the gynaecologist but the patient may continue
normal daily activities. The PDT procedure removes cervical abnormalities while
preserving the normal tissue.
Photocure has patents in cervical disease until 2030.
About Photocure
Photocure is a Norwegian pharmaceutical company listed on the Oslo Stock
Exchange (OSE: PHO). The company develops and sells pharmaceuticals and medical
devices for the photodynamic treatment and diagnosis of cancer and selected
dermatology indications.
Photocures commercial activities includes own marketing and sales in selected
markets as well as out-licensing to leading pharmaceutical companies on a
regional or global basis prior to phase III.
Photocure has one proprietary pharmaceutical product on the market: Hexvix®, for
the diagnosis of bladder cancer. Hexvix is approved in EU and in the US. In
addition, the company has developed a proprietary light source, which is used in
combination with the Visonac(TM) cream. Through worldwide studies, Photocure is
continuously testing its products for new indications, and the aim is to develop
a pipeline of follow-on products based on the Photocure Technology(TM) platform.
Photocure® and Hexvix® are registered trademarks of Photocure ASA.
For more information about Photocure, visit our website atwww.photocure.com
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
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